The existing application procedures for fast-track (FTP) and temporary authorisations (temp.auth.) are to be replaced by the Accelerated Application Hearing (AAA) meeting with the applicant.
The introduction of the AAA allows Swissmedic to discuss planned FTP and temp.auth. procedures with the applicant at an early stage. The AAA can take place between 2 and 12 months before the submission of the authorisation application. During the hearing, Swissmedic discusses with the applicant whether a procedure for an FTP or temporary authorisation is possible on the basis of the scientific documentation submitted with the application for an AAA.
Depending on the outcome of the review of the submitted scientific documentation and the supplementary reasons presented to the applicant during the AAA, Swissmedic will reach a binding decision during the AAA on the procedural route. Swissmedic therefore assumes that at least one authorised signatory with decision-making powers will represent the applicant at the AAA.
Following the AAA, the applicant will receive the decision in writing in the form of an official order. The signed decision minutes (i.e. the rationale for the decision) produced at the AAA and signed by Swissmedic and the applicant form an integral part of the official decision.
Swissmedic invoices the applicant for its costs incurred by the AAA based on the workload (review of the submitted documentation and the implementation of the AAA). The fee is based on the administrative and scientific work involved in accordance with Art. 4 FeeO-Swissmedic[1].
The application for an AAA for an FTP or temp.auth. procedure is optionally possible from 1 January 2021. From 1 April 2021, the AAA will replace the existing application procedure for an FTP or temporary authorisation of human medicinal products.
Swissmedic has updated the guidance documents Fast-track authorisation procedure HMV4 / Temporary authorisation for human medicinal products HMV4 accordingly.
[1] SR 812.214.5